Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087955
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VITAMIN K1 | PHYTONADIONE | 10MG/ML | INJECTABLE;INJECTION | Prescription | AB1 | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/25/1983 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/087955.PDF |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/07/2004 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/27/2003 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/19/1999 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/02/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/28/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/15/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/22/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/04/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
VITAMIN K1
INJECTABLE;INJECTION; 10MG/ML
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PHYTONADIONE | PHYTONADIONE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB1 | 219212 | CAPLIN |
| PHYTONADIONE | PHYTONADIONE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB1 | 207719 | DR REDDYS |
| PHYTONADIONE | PHYTONADIONE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB1 | 217386 | GLAND |
| PHYTONADIONE | PHYTONADIONE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AB1 | 215090 | SUNNY |
| VITAMIN K1 | PHYTONADIONE | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AB1 | 087955 | HOSPIRA |